Effects of Oriental Music on Preterm Infants

Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)

The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.

Study Overview

• Status: Terminated
• Conditions: Premature; Behavior, Child
• Intervention / Treatment: Other: Music exposure; Other: Silence

Detailed Description

Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.

We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 1107 2020
    • American University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
• Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.

Exclusion Criteria:

• Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
• Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oriental music; Infants assigned to this group will be exposed to oriental music.	Other: Music exposure; Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Active Comparator: Western music; Infants assigned to this group will be exposed to western music.	Other: Music exposure; Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Placebo Comparator: Silence / control; Infants assigned to this group will be exposed to the same protocol but using a track of silence.	Other: Silence; Participants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.; Other Names: No music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Respiratory rate	The respiratory rate will be retrieved from bedside monitors.	3 years
Oxygen Saturation	The oxygen saturation will be retrieved from bedside monitors.	3 years
Behavioral state	The behavioral score will be assessed using a 7- point score by a certified nurse.	3 years

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Lama Charafeddine, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Heart rate variability; Music therapy; Premature infant; Behavior state
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: SBS-2020-0284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No